The present invention relates to a new and novel intraluminal graft/stent and a method for implantation and is more specifically related to an intraluminal graft/stent particularly well suited for non-invasive treatment of aortic aneurysms and diseased blood vessels.
The treatment of aortic aneurysms usually involves invasive surgery in which the abdominal and/or chest cavity of the patient is opened in order to gain access for treatment of the aorta. One such procedure is described in a book entitled Surgical Treatment of Aortic Aneurysms by Denton A. Cooley, M.D., published in 1986 by W. B. Saunders Company.
Additionally, blood vessels can become diseased and the lumen narrowed by atherosclerosis ("hardening of the arteries"). These diseased vessels are presently being opened via numerous angioplastic methods. In order to prevent restenosis, various and currently available stents can be implanted. The present invention is also particularly well-suited to this application.
The device of the present invention will hereinafter be referred to as "intraluminal graft"; however, the breadth of scope of the application should be recognized in that it can be used as a graft to repair aortic or other aneurysms or as a stent in holding open a blood vessel segment which would otherwise have a tendency to become narrowed.
The present invention also relates to a method and a balloon catheter for insertion of such intraluminal graft in a blood vessel.
Treatment of some aneurysms through non-invasive procedures has been known in the art, U.S. Pat. No. 4,740,207 discloses an intraluminal graft specifically designed for non-invasive repairs to damaged blood vessels. It consists of a graft element form of a rolled, generally rectangular section of resilient material suitable for long term residence inside the vessel and expandable substantially uniformly over its entire length from a relaxed small diameter to one or more larger diameters. The graft element is formed with a retaining means extending generally along one of two longitudinal edges. Following positioning in the vessel, the graft element is caused to expand from the smaller diameter to a larger diameter. Such expansion results in the other of the longitudinal edges engaging the retaining means to hold the graft in the expanded position within the vessel. As stated in such patent, the intralumenal graft disclosed therein is particularly well-suited for aneurysm repair by the method disclosed in U.S. Pat. No. 4,577,631.
U.S. Pat. No. 4,577,631 discloses a method and apparatus for repairing aortic aneurysms without surgically invading the abdominal cavity. In the procedure disclosed therein, an occlusion catheter is introduced into a blood vessel down stream of the damaged aorta and fed to a point above the damaged area where it is opened to block the flow of the blood. A tubular prosthetic graft coated with contact adhesive is received about a collapsed balloon catheter which is used to inset the graft into position. The balloon catheter is then expanded to bring the graft into contact with healthy walls of the vessel on either side of the damaged section. Once the graft is permanently adhered to the vessel walls, the two catheters are withdrawn.
U.S. Pat. No. 4,271,839 to Thomas J. Fogarty et al., discloses a balloon catheter and method for dilating a partially occluded section of a blood vessel and includes balloon means inverted within the catheter and having a mouth peripherally sealed to the distal end. The balloon is evertable out of the catheter in response to the exertion of fluid pressure within the catheter and laterally expansible in response to continued exertion of internal fluid pressure to dilate the occlusion.
U.S. Pat. No. 4,776,337 to Julio C. Palmaz discloses an expandable intraluminal graft and method and apparatus for implanting within a body passageway such as a blood vessel. The apparatus comprises a catheter having an expansible balloon and means for mounting and retaining the graft during insertion in the body.
U.S. Pat. No. 4,762,132 discloses a catheter having a helical balloon attached to its distal end which serves, when inflated as a therapeutic tool for removal of blood clots.
U.S. Pat. No. 4,195,637 discloses a catheter having a flexible dilation element comprising a cylindrical foldable wall and two lumens, one for dilating the flexible dilating element and the other for infeeding blood or a contrast agent into the blood vessel.
The disclosures of the above patents are incorporated herein by reference and copies are herewith enclosed.